Wednesday, August 22, 2012

Topic10: MA Reporting Relationships in Small Companies

A reader wrote in to discuss a situation at a small pharma company. This company was just starting up its MA group and it was not sure where the MA group should report. The reader was well aware of the issues with having MA report to a commercial leader that we discussed in this post.

The challenge in this situation was that senior management consisted currently of just a CEO and a COO. While the CEO is a scientist who handles their development efforts, the COO handles all other responsibilities, including Commercial, Finance, Legal and HR. The CEO would be the natural choice for managing MA, but given workloads it was not practically feasible. Could the COO handle the job of managing MA even though they also have some commercial responsibilities without putting the company at risk?

This is a very common situation for young organizations. There is often very little senior leadership to go around. Yet, as we mentioned in this post, it is critical to start MA up early to support a product launch that may be over two years away. In situations where it is not feasible for MA to report to someone purely on the science side and they need to report to someone with commercial responsibilities, my rule of thumb is that the role they report to should have substantial responsibilities outside of commercial and should be measured on results that go beyond just commercial measures.

In the case above, the COO has commercial responsibilities but they also have non-commercial responsibilities as well. Having MA report to the COO should not be a problem, as long as the COO understands the role of a compliant MA organization and follows the general rule about MA interactions with commercial that were outlined here. In the end, the Agency looks for actions not reporting relationships, but the reporting relationship do send a clear signal about the priorities of the MA organization.

What has been your experience about MA reporting relationships? Please leave a comment below. And if you are new to the blog please sign up for email updates by clicking on the link to the right.

Completely agree with CV's comment. While I did not discuss budgets in this post, anything that results in commercial "calling the shots" for MA would be a major compliance risk. Thanks for the comment